Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar

PLoS One. 2016 Apr 1;11(4):e0152304. doi: 10.1371/journal.pone.0152304. eCollection 2016.

Abstract

Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Correct diagnosis of G6PD status in patients is crucial for safe treatment of both relapsing stages of Plasmodium vivax and transmitting forms of Plasmodium falciparum. Lack of suitable point-of-care tests has hampered a much needed wide use of primaquine for malaria elimination. In this study we have assessed the performances of two qualitative tests, the fluorescent spot test (FST) and the G6PD CareStart test (CST), against the gold standard quantitative spectrophotometric assay in a population of 1000 random adult healthy volunteers living in Yangon, Myanmar. The prevalence of G6PD deficiency in the Bamar, Karen and in the whole sample set was 6.6% (10.1% in males), 9.2% (21.0% in males) and 6.8% (11.1% in males) respectively. The FST and CST showed comparable performances with sensitivity over 95% and specificity over 90%, however for cases with severe G6PD activity the FTS had improved performance. If used with a conservative interpretation of the signal, the CareStart test has the potential to be used in the field and, by allowing a wider use of primaquine, to help malaria elimination.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Antimalarials / therapeutic use
  • Equipment Design
  • Female
  • Fluorescence
  • Glucosephosphate Dehydrogenase / blood*
  • Glucosephosphate Dehydrogenase Deficiency / blood*
  • Glucosephosphate Dehydrogenase Deficiency / diagnosis*
  • Glucosephosphate Dehydrogenase Deficiency / epidemiology
  • Healthy Volunteers
  • Humans
  • Malaria, Falciparum / drug therapy
  • Malaria, Vivax / drug therapy
  • Male
  • Middle Aged
  • Myanmar / epidemiology
  • Plasmodium falciparum / drug effects
  • Plasmodium vivax / drug effects
  • Point-of-Care Systems*
  • Primaquine / therapeutic use
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity

Substances

  • Antimalarials
  • Reagent Kits, Diagnostic
  • Glucosephosphate Dehydrogenase
  • Primaquine